Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)

Inclusion Criteria:

prospective specimens:

Patient is at least 18 years of age
Patient has provided documented informed consent as required by the reviewing IRB. Experimental Bill of Rights will also be documented for all subjects enrolled in applicable states.
Patient has been diagnosed with CML.
Patient consents to provide at least 12 mL of peripheral blood for study purposes

frozen specimens:

Specimen is from a subject diagnosed with CML
Specimen meets the manufacturer's criteria to support testing by both diagnostic assays

Exclusion Criteria:

prospective specimens:

Patient is considered to be of insufficient health to supply the required volume of peripheral blood by his/her health care provider
Patient has been previously enrolled
frozen specimens: • Specimen previously enrolled